Trial Outcomes & Findings for BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis (NCT NCT03482635)

Last Updated: 2025-10-16

Results Overview

Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 \[if drop ≥1 from baseline\] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12. Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

98 participants

Primary outcome timeframe

At week 12.

Results posted on

2025-10-16

Participant Flow

Phase II/III randomized, placebo-controlled, double-blind trial to assess the safety and efficacy of spesolimab induction therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy. Phase III was not conducted, due to recruitment issues in Phase II.

Only subjects that met all the study inclusion and non of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.

Participant milestones

Participant milestones
Measure	Placebo A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Overall Study STARTED	23	24	23	28
Overall Study Treated	23	24	23	27
Overall Study COMPLETED	18	21	22	20
Overall Study NOT COMPLETED	5	3	1	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Overall Study Lack of Efficacy	0	0	1	3
Overall Study Adverse Event	2	2	0	3
Overall Study Withdrawal by Subject	2	1	0	1
Overall Study Withdrawn by Principle Investigator	1	0	0	0
Overall Study Not treated	0	0	0	1

Baseline Characteristics

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=23 Participants A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD n=24 Participants A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w n=23 Participants 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w n=28 Participants 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	Total n=98 Participants Total of all reporting groups
Age, Continuous	42.2 Years STANDARD_DEVIATION 14.1 • n=5 Participants	41.4 Years STANDARD_DEVIATION 14.6 • n=7 Participants	42.3 Years STANDARD_DEVIATION 15.3 • n=5 Participants	43.9 Years STANDARD_DEVIATION 14.9 • n=4 Participants	42.5 Years STANDARD_DEVIATION 14.6 • n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	36 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	20 Participants n=4 Participants	62 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	27 Participants n=4 Participants	97 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	23 Participants n=7 Participants	18 Participants n=5 Participants	21 Participants n=4 Participants	80 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: At week 12.

Population: Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD n=24 Participants A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w n=23 Participants 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w n=28 Participants 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Proportion of Patients With Clinical Remission at Week 12	0.00 Proportion of Participants Interval 0.0 to 0.143	0.042 Proportion of Participants Interval 0.007 to 0.202	0.087 Proportion of Participants Interval 0.024 to 0.268	0.071 Proportion of Participants Interval 0.02 to 0.226

SECONDARY outcome

Timeframe: At week 12.

Population: Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.

Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) ≤ 1 or decrease by ≥1 from baseline; and total Mayo Clinical Score (MCS) decrease by ≥ 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are calculated using the method of Wilson.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD n=24 Participants A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w n=23 Participants 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w n=28 Participants 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Proportion of Patients With Clinical Response at Week 12	0.217 Proportion of participants Interval 0.097 to 0.419	0.167 Proportion of participants Interval 0.067 to 0.359	0.261 Proportion of participants Interval 0.125 to 0.465	0.250 Proportion of participants Interval 0.127 to 0.434

SECONDARY outcome

Timeframe: At week 12.

Population: Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.

Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD n=24 Participants A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w n=23 Participants 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w n=28 Participants 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Proportion of Patients With Endoscopic Improvement at Week 12	0.000 Proportion of participants Interval 0.0 to 0.143	0.083 Proportion of participants Interval 0.023 to 0.258	0.087 Proportion of participants Interval 0.024 to 0.268	0.071 Proportion of participants Interval 0.02 to 0.226

SECONDARY outcome

Timeframe: At week 12.

Population: Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation.

Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1 and Robarts Histology Index ≤ 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD n=24 Participants A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w n=23 Participants 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w n=28 Participants 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12	0.00 Proportion of participants Interval 0.0 to 0.143	0.083 Proportion of participants Interval 0.023 to 0.258	0.043 Proportion of participants Interval 0.008 to 0.21	0.036 Proportion of participants Interval 0.006 to 0.177

SECONDARY outcome

Timeframe: At baseline and at week 12.

Population: Modified Randomised Set (m-RS): The m-RS included all patients in the RS who had a baseline and at least 1 post-baseline measurement for the endpoint under consideration. Treatment assignment was randomised.

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12. The IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID). Mean is adjusted mean.

Outcome measures

Outcome measures
Measure	Placebo n=18 Participants A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD n=19 Participants A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w n=21 Participants 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w n=18 Participants 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12	19.8 Score on a scale Interval 4.7 to 35.0	19.5 Score on a scale Interval 4.6 to 34.5	21.2 Score on a scale Interval 6.6 to 35.9	20.8 Score on a scale Interval 6.3 to 35.4

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

300 mg Spesolimab (BI 655130) SD

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

450 mg Spesolimab (BI 655130) q4w

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

1200 mg Spesolimab (BI 655130) q4w

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=23 participants at risk A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD n=24 participants at risk A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w n=23 participants at risk 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w n=27 participants at risk 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Blood and lymphatic system disorders Anaemia	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	3.7% 1/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Colitis ulcerative	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	8.3% 2/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Femur fracture	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	4.2% 1/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.

Other adverse events

Additional Information

Boehringer Ingelheim, Call Centre

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation of review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=23 participants at risk A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	300 mg Spesolimab (BI 655130) SD n=24 participants at risk A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	450 mg Spesolimab (BI 655130) q4w n=23 participants at risk 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.	1200 mg Spesolimab (BI 655130) q4w n=27 participants at risk 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
Blood and lymphatic system disorders Anaemia	21.7% 5/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	4.2% 1/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	8.3% 2/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	22.2% 6/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
General disorders Fatigue	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
General disorders Feeling hot	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	13.0% 3/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Infections and infestations Herpes zoster	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	8.3% 2/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	8.7% 2/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	3.7% 1/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	4.2% 1/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	11.1% 3/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Nervous system disorders Syncope	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	8.3% 2/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	8.7% 2/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	0.00% 0/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	4.2% 1/24 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	8.7% 2/23 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.	7.4% 2/27 • From screening until end of study, up to 29 weeks. Safety Analysis Set (SAF): All patients who were randomised and received at least one dose of study drug.